Correct Endotracheal Tube Placement Using Topographical Landmarks

NCT05439109 | Unknown DMC FDA Device

• 1 other identifier: RES/SCM/35/2019/68
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.

Conditions

Intubation, Intratracheal; Anatomic Landmarks

Keywords

Endotracheal tube placement; Topographical landmarks of trachea

Outcome Measures

Primary Outcomes (1)

• Endotracheal tube position inside the trachea

  Tip to carina distance will be measured by fiber optic bronchoscopy to classify the optimal or suboptimal tube placements in both groups

  through study completion approximately at six months

Study Arms (2)

Topographical landmark technique

EXPERIMENTAL

Surface anatomic landmarks of an individual's trachea will be measured from the mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane to estimate tracheal length. Three centimeters will be deducted from the estimated tracheal length to provide the length of the endotracheal tube from the tube tip to be inserted inside the trachea.

Device: Topographical landmark technique of endotracheal tube placement

Intubation guide mark technique

ACTIVE COMPARATOR

Already established and commonly practiced technique, in this technique, the guide mark present above the proximal end of the endotracheal tube cuff will be placed just beyond the vocal cords.

Device: Intubation guide mark technique of endotracheal tube placement

Interventions

Topographical landmark technique of endotracheal tube placement DEVICE

An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions.

Topographical landmark technique

Intubation guide mark technique of endotracheal tube placement DEVICE

An endotracheal tube will be placed in this group by using the intubation guide mark.

Intubation guide mark technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group of 18-75 years
• ASA physical status I-III patients
• Oral intubation for general anesthesia

You may not qualify if:

• Patient with upper airway fibrosis
• Tracheal stenosis or tracheal surgeries
• Previous head and neck surgeries
• Contracture neck or irradiated neck
• Large neck swelling distorting or deviating the trachea
• Laryngeal or tracheal tumor
• Intubations requiring flexo-metallic tubes
• Patient refusal

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (1)

Amit

Rohini, National Capital Territory of Delhi, 110085, India

Location

Study Officials

• Amit K Mittal, M.D

  Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit K Mittal, M.D

CONTACT

09717611416; amitrgci@gmail.com

Anil K Patel, DNB

CONTACT

09781364051; anilpatel2811@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The primary investigator will provide the information regarding the portion of endotracheal to be kept below the vocal cords to the care provider after measuring the dimensions of the trachea topographically. After tube placement, the tube tip to carina distance will be measured in both topographical and intubation guide mark technique.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All enrolled patients will be intubated by either topographical landmarks of individual tracheal dimensions or by the conventional intubation guide method.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

IN (1)